Made in Chi­na: TaiMed wins FDA OK for a 'break­through' HIV ther­a­py for drug-re­sis­tant pa­tients

The FDA has hand­ed TaiMed and its part­ners at Ther­at­e­ch­nolo­gies an ap­proval for the first new HIV drug to come along in a decade with a nov­el mech­a­nism of ac­tion.

The drug, to be mar­ket­ed as Trog­a­r­zo (ibal­izum­ab-uiyk), works by bind­ing to the sec­ond ex­tra­cel­lu­lar do­main of the CD4+ T cell re­cep­tor, away from oth­er bind­ing sites used by drugs al­ready on the mar­ket. That ap­proach al­lows pa­tients who are be­com­ing re­sis­tant to their ther­a­pies to add this to the mix be­fore be­ing ex­posed to a lethal amount of virus.

Tai­wan-based TaiMed of­fered enough da­ta from a mid-stage pro­gram to war­rant both a break­through ther­a­py des­ig­na­tion as well as a pri­or­i­ty re­view for this drug, slic­ing the time need­ed for an FDA in­spec­tion.

For a low pro­file ther­a­py, this drug is a re­mark­able trend­set­ter in many ways. Shang­hai-based WuXi Bi­o­log­ics — part of Ge Li’s ex­pan­sive bio­phar­ma em­pire — will man­u­fac­ture the drug, and the FDA com­plet­ed its first-ever in­spec­tion and ap­proval of a Chi­nese man­u­fac­tur­ing fa­cil­i­ty to lay the foun­da­tion for the com­mer­cial roll­out.

“While most pa­tients liv­ing with HIV can be suc­cess­ful­ly treat­ed us­ing a com­bi­na­tion of two or more an­ti­retro­vi­ral drugs, a small per­cent­age of pa­tients who have tak­en many HIV drugs in the past have mul­tidrug re­sis­tant HIV, lim­it­ing their treat­ment op­tions and putting them at a high risk of HIV-re­lat­ed com­pli­ca­tions and pro­gres­sion to death,” said Jeff Mur­ray, deputy di­rec­tor of the Di­vi­sion of An­tivi­ral Prod­ucts in the FDA’s CDER. “Trog­a­r­zo is the first drug in a new class of an­ti­retro­vi­ral med­ica­tions that can pro­vide sig­nif­i­cant ben­e­fit to pa­tients who have run out of HIV treat­ment op­tions. New treat­ment op­tions may be able to im­prove their out­comes.”

TaiMed out-li­censed the drug to Mon­tre­al-based Ther­at­e­ch­nolo­gies a cou­ple of years ago in a deal that starts very small. The biotech bagged just a mil­lion dol­lars, ini­tial­ly, with an­oth­er mil­lion due on launch. There’s a few mil­lion more in shares for var­i­ous con­di­tions, and $10 mil­lion once an­nu­al sales of $200 mil­lion are reached in the US. That goes up to a $100 mil­lion if they can break the $1 bil­lion mark.

Ther­at­e­ch­nolo­gies al­so agreed to a de­vel­op­ment mile­stone for Phase III of $50 mil­lion, paid quar­ter­ly.

In­vestors liked the sound of all of it. Ther­at­e­ch­nolo­gies’ shares $THERF soared 30% on the news.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.